240339
IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Level
体外诊断检测试剂/试剂盒、临床化学、酒精含量
Microgenics Corporation·B·Hong Kong MDACS·Registered August 08, 2024
Device overview
- Risk class
- B
- Product code
- 18930
- State
- current
- Status
- N/A
- Product code detail
- 18930 IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Level
Manufacturer (製造商)
- Name
- Microgenics CorporationMicrogenics Corporation
- Country
- United States美国
- Address
- 46500 Kato Road, Fremont CA 94538, USA46500 Kato Road, Fremont CA 94538, 美国
Authorised representative (AR)
- Name
- Thermo Fisher Scientific (Hong Kong) Limited赛默飞世尔科技(香港)有限公司
- Phone
- 31077600
Regulatory timeline
- Registration date
- August 08, 2024
- Expiry date
- August 07, 2029
Product models
DRI Ethyl Alcohol Assay (10016397, 0037, 0038), DRI Negative Alcohol Calibrator (0311, 1405), DRI 100 mg/dL Alcohol Calibrator (0241, 1406), DRI 50 mg/dL Alcohol Control (0239), DRI 300 mg/dL Alcohol Control (0243)
DRI 乙醇测定 (10016397, 0037, 0038), DRI 阴性酒精校准品 (0311, 1405), DRI 100 mg/dL 酒精校准品 (0241, 1406), DRI 50 mg/dL 酒精对照品 (0239), DRI 300 mg/dL 酒精对照品 (0243)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Level. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Level
產品資訊： 体外诊断检测试剂/试剂盒、临床化学、酒精含量